Whether the Medicare Act requires coverage of medically necessary enteral formula as a prosthetic device for patients with rare metabolic disorders who cannot metabolize proteins through standard nutrition

No question identified. : To the Honorable Brett M. Kavanaugh, as Circuit Justice for the United States Court of Appeals for the Sixth Circuit: Pursuant to this Court’s Rules 13.5, 22, 30.2, and 30.3, Petitioner Therese M. Waters, on behalf of Kelly E. Waters, respectfully requests that the time to file her Petition for Writ of Certiorari in this matter be extended 45 days, up to and including March 15, 2024. The Sixth Circuit Court of Appeals issued its Opinion on September 11, 2023. That Opinion and the Court’s Judgment are attached. The Court of Appeals denied rehearing and rehearing en banc on November 1, 2023. That Order is also attached. Absent an extension of time, the Petition for Writ of Certiorari would be due on January 30, 2023. Petitioner is filing this Application more than 10 days before that date. S. Ct. R. 13.5. This Court would have jurisdiction over the judgment under 28 U.S.C. 1254(1). Respondent, through his counsel, does not object to the requested extension. Introduction The Secretary provides enteral formula benefit coverage as a prosthetic device under 42 U.S.C. §1395x(s)(8) to Medicare beneficiaries suffering from gastrointestinal tract dysfunctions who cannot ingest regular foods and are treated with enteral formula administered through a feeding tube. The Secretary denied enteral formula benefit coverage as a prosthetic device under 42 U.S.C. §1395x(s)(8) to the Beneficiary who suffers from Homocystinuria, a genetic defect which prevents her liver from metabolizing the proteins in regular foods, because she takes her enteral formula orally, not through a feeding tube. The Secretary thus denied coverage based upon which of the Beneficiary’s internal organs is dysfunctional and the means of delivering her enteral formula. He did so notwithstanding the fact that the Medicare Act covers all internal organ dysfunctions except for dental. The Secretary argued that “... even if this Court concluded that the relevant authorities were ambiguous, it should still affirm because the Secretary’s interpretation is entitled to deference.”! Both lower Courts deferred to the Secretary’s interpretation of his Medicare contractor’s Policy Article notwithstanding the fact that the Policy Article did not specifically exclude coverage for persons with permanent impairments and offered no reason whatsoever for doing so. This case presents questions of significant jurisprudential importance. 50% of homocystinuria patients die before age 25 if not treated.2 The Circuit Court’s holding that enteral formula is not a covered benefit will affect beneficiaries suffering from at least five rare amino acid metabolism disorders: Homocystinuria, Argininosuccinic Acidemia, Citrullinemia, Maple Syrup Urine Disease (MSUD) and Phenylketonuria (PKU), each of which has been detected in the population at a rate of between 0.36 to 4.64 persons per 100,000 and all of which are treated by “Life-long, orallyadministered” amino acid modified enteral formulas.*® There are also three Organic Acid Metabolism Disorders and one Fatty Acid Disorder that will be affected by the decision in this case.‘ In a country of 335,000,000, the Secretary’s decision to exclude those beneficiaries from enteral formula benefit coverage will affect tens of thousands of persons. 1 Brief of Appellee, Document 22, Pages: 30, 34-38. 2 ECF No. 13, PageID #303. 3 ECF No. 13, PageID #308. 4 Id. Background The Beneficiary’s University of Michigan physician and medical professor prescribed an orally administered amino acid modified enteral formula to treat her homocystinuria. That enteral formula omits the amino acid methionine that the Beneficiary’s liver cannot metabolize and contains the amino acid L-cysteine that her liver cannot produce. The Beneficiary’s enteral formula is only available by prescription and is classified by the FDA as “a medical food defined in section 5(b)(8) of the Orphan Drug Act (21 U.S.C. §360ee(b)(3)) [as] ‘a food which is formulated to be cons